CDRH Advisory Committee Meeting: Orthopedic and Rehabilitation Devices Panel

1. CDRH Advisory Committee Meeting:Orthopedic and RehabilitationDevices Panel November 20, 2002 INDEPENDENCE™ iBOT™ 3000 Mobility System Independence Technology

2. Question 1 • Electromagnetic Compatibility: Are the electromagnetic compatibility (EMC) testing and labeling (e.g., regarding use of cell phones) sufficient to mitigate the risks in a changing electromagnetic environment over which the user has limited control? If not, what additional measures are recommended?

3. Question 2 • Clinician Certification: The sponsor proposes that clinicians obtain certification in order to be able to assess and train prospective iBOT™ users. Is the proposed clinician certification process adequate for assuring that clinicians can identify appropriate users and train them to use the iBOT™ in a safe and effective manner?

4. Question 3 • User Training: The sponsor proposes a number of procedures to assess and train potential iBOT™ users. Are these user assessment and training procedures adequate for assuring safe and effective use of the iBOT™ ?

5. Question 4 • Device Safety: The sponsor conducted a clinical trial that compared 2 weeks of iBOT™ usage to 2 weeks of subjects’ own mobility devices usage. The sponsor provided safety data that included summaries of injuries, physical device failures (e.g., device and component replacements) and other events (e.g., falls, intentional device actions, such as system shutdown) that could place the user at risk of injury due to user error and/or device design limitations. Given these data, has reasonable assurance of device safety been demonstrated?

6. Question 5 • Device Effectiveness: The sponsor conducted a clinical trial that compared 2 weeks of iBOT™ usage to 2 weeks of subjects’ own mobility devices usage. The following data were included in support of effectiveness of the iBOT™: • a) Primary and Secondary Outcome Measures • i) Community Driving Scores (primary) • ii) Subject Specific Function Scale (secondary) • b) Additional Effectiveness Data • i) Data Logger Distributions (e.g., computerized usage data as well as computerized alert and failure action counts) • ii) Device Failures (e.g., required component or device replacements) • iii) Daily Activity Logs • (1) Accessibility Problems • (2) Mechanical /Operational Difficulties • (3) Subjective Evaluation of Home and Community Maneuvering • The primary and secondary outcome measures (item a) yielded statistically significant results in favor of the iBOT™. In light of the results of the primary and secondary outcome measures and the additional data collected (as noted in item b above), has reasonable assurance of device effectiveness been demonstrated?

7. Question 6 • Post-market Data Collection: This PMA study was conducted with 18 subjects, most of whom had a spinal cord injury, and allowed for 2 weeks of iBOT™ usage. If you recommend that this device is approvable, are there any data that should be collected during the post-market period? For instance, post-market data could be collected for the following purposes: • Clarifying labeling, for example: • Better define the user population(s) best suited for this device; • Better define long-term usage trends/profiles; and • Better define adverse event rates • Refine assessment and training procedures for clinicians and iBOT™ users